Investigating the Structured Use of Ultrasound Scanning for Fetal Growth

Fetal Growth Retardation Clinical Trial

— OxGRIP  

Official title:

Investigating the Structured Use of Ultrasound Scanning for Fetal Growth (Oxford Growth Restriction Identification Programme (OxGRIP)) on Risk Factors for and the Incidences of Adverse Maternal, Fetal and Neonatal Outcome

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03662178
• Other study ID #: 17/SC/0374
• Status: Recruiting
• Start date: September 1, 2017
• Est. completion date: September 30, 2029

Study information

• Verified date: December 2023
• Source: Oxford University Hospitals NHS Trust
• Contact: Lawrence Impey
• Phone: 01865 851165
• Email: lawrence.impey[@]ouh.nhs.uk
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Fetal growth restriction during pregnancy represents one of the biggest risk factors for stillbirth (Gardosi et al, 2013), with 'about one in three term, normally formed antepartum stillbirths are related to abnormalities of fetal growth' (MBRRACE, 2015). Therefore, antenatal detection of growth restricted babies is vital in order to be able to monitor and decide the appropriate delivery timing. However, antenatal detection of SGA babies has been poor, varying greatly across trusts in England in those that calculate their rates (NHS England, 2016). Most trusts do not calculate their detection rates and rates are therefore unknown. It is estimated that routine NHS care detects only 1 in 4 growth restricted babies (Smith, 2015). Oxford University Hospitals NHS Foundation Trust, in partnership with the Oxford Academic Health Science Network (AHSN) has introduced a clinical care pathway (the Oxford Growth Restriction Pathway (OxGRIP)) designed to increase the rates of detection of these at risk babies. The pathway is intended to increase the identification of babies who are at risk of stillbirth, in order to try to prevent this outcome, whilst making best usage of resources, and restricting inequitable practice and unnecessary obstetric intervention. It has been developed with reference to a body of research, however, the individual parts of care provided have not been put together in a pathway in this manner before. Therefore it is important to examine whether the pathway meets its goals of improving outcomes for babies in a 'real world' setting. The principles of the pathway are 1. A universal routine scan at 36 weeks gestation. 2. Additional growth scans at 28 and 32 weeks gestation based on a simplified assessment of risk factors and universal uterine artery Doppler at 20 weeks gestation. 3. Assessment of further parameters other than estimated fetal weight associated with adverse perinatal outcome (eg growth velocity, umbilical artery Doppler and CPR). The clinical data routinely collected as a result of the introduction of the pathway offers a valuable and unique resource in identifying and analysing in the effects of the pathway on its intended outcomes and also in investigating and analysing other maternal, fetal and neonatal complications and outcomes, establishing normal / reference ranges for ultrasound values.

Description:

There is no requirement for patient participation in this study. All data collected and analysed is routinely collected clinical data.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 56000
• Est. completion date: September 30, 2029
• Est. primary completion date: September 30, 2029
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 16 Years to 60 Years

Eligibility

Inclusion Criteria:

• All pregnant women receiving antenatal care at the Oxford University Hospitals NHS Foundation Trust (OUHFT) from January 2013 to 31st December 2019 with no exclusion criteria

Exclusion Criteria:

• Women who have opted out of research related to pregnancy in this pregnancy whilst receiving care by the OUHFT.
• If intrapartum care takes place outside of the OUHFT.

Related Conditions & MeSH terms

• Death
• Fetal Death
• Fetal Growth Restriction
• Fetal Growth Retardation
• Intrauterine Growth Restriction
• Perinatal Death
• Small for Gestational Age
• Stillbirth

Locations

Country	Name	City	State
United Kingdom	Oxford University Hospitals NHS Foundation Trust	Oxford	Oxfordshire

Sponsors (1)

Lead Sponsor	Collaborator
Oxford University Hospitals NHS Trust

Country where clinical trial is conducted

United Kingdom, 

References & Publications (6)

Chauhan SP, Magann EF. Screening for fetal growth restriction. Clin Obstet Gynecol. 2006 Jun;49(2):284-94. doi: 10.1097/00003081-200606000-00010. — View Citation

Gardosi J, Francis A. Adverse pregnancy outcome and association with small for gestational age birthweight by customized and population-based percentiles. Am J Obstet Gynecol. 2009 Jul;201(1):28.e1-8. doi: 10.1016/j.ajog.2009.04.034. — View Citation

Gardosi J, Madurasinghe V, Williams M, Malik A, Francis A. Maternal and fetal risk factors for stillbirth: population based study. BMJ. 2013 Jan 24;346:f108. doi: 10.1136/bmj.f108. — View Citation

Papageorghiou AT, Kennedy SH, Salomon LJ, Ohuma EO, Cheikh Ismail L, Barros FC, Lambert A, Carvalho M, Jaffer YA, Bertino E, Gravett MG, Altman DG, Purwar M, Noble JA, Pang R, Victora CG, Bhutta ZA, Villar J; International Fetal and Newborn Growth Consortium for the 21st Century (INTERGROWTH-21st). International standards for early fetal size and pregnancy dating based on ultrasound measurement of crown-rump length in the first trimester of pregnancy. Ultrasound Obstet Gynecol. 2014 Dec;44(6):641-8. doi: 10.1002/uog.13448. Epub 2014 Nov 2. — View Citation

Sovio U, White IR, Dacey A, Pasupathy D, Smith GCS. Screening for fetal growth restriction with universal third trimester ultrasonography in nulliparous women in the Pregnancy Outcome Prediction (POP) study: a prospective cohort study. Lancet. 2015 Nov 21;386(10008):2089-2097. doi: 10.1016/S0140-6736(15)00131-2. Epub 2015 Sep 7. Erratum In: Lancet. 2015 Nov 21;386(10008):2058. — View Citation

Stacey T, Thompson JM, Mitchell EA, Zuccollo JM, Ekeroma AJ, McCowan LM. Antenatal care, identification of suboptimal fetal growth and risk of late stillbirth: findings from the Auckland Stillbirth Study. Aust N Z J Obstet Gynaecol. 2012 Jun;52(3):242-7. doi: 10.1111/j.1479-828X.2011.01406.x. Epub 2012 Jan 25. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Impact of OxGRIP on Perinatal mortality according to gestation	Mortality (stillbirth and neonatal death per 1000 pregnancies) in the period after birth) assessed in 2 years before the programme and compared with the 2 years after the programme started. Assessed for all pregnancies and for those reaching 35 weeks' gestation	4 yrs
Secondary	Impact of the OxGRIP Pathway on service: number of scans	Number of Ultrasound Scans (>24 weeks gestation) performed per pregnancy	6 yrs
Secondary	Impact of the OxGRIP Pathway on service - Consultant time	Number of Consultant appointments	6 yrs
Secondary	Impact of the OxGRIP Pathway on service - intrapartum interventions	Proportion of all birth delivered as emergency and elective cesarean sections and instrumental deliveries	6 yrs
Secondary	Risk Factors for adverse outcomes - ultrasound head circumference	Routinely collected ultrasound fetal measurements - Head Circumference. Physiological parameter	4 yrs
Secondary	Risk Factors for adverse outcomes - ultrasound abdomen circumference	Routinely collected ultrasound fetal measurements - Abdominal Circumference.Physiological parameter	4 yrs
Secondary	Risk Factors for adverse outcomes - ultrasound femur length	Routinely collected ultrasound fetal measurements - Femur Length. Physiological parameter	4 yrs
Secondary	Risk Factors for adverse outcomes - ultrasound presentation	Fetal presentation at last scan before birth. Physiological parameter	4 yrs
Secondary	Risk Factors for adverse outcomes - Doppler ultrasound	Uterine/umbilical artery/ middle cerebral artery Doppler values. Physiological parameter	4 yrs
Secondary	Clinical outcomes during pregnancy and postnatal/neonatal period: hypertension	Diagnosis of pre eclampsia and related complications. Physiological parameter	4 yrs
Secondary	Clinical outcomes during pregnancy and postnatal/neonatal period: diabetes	Diagnosis of Gestational Diabetes. Physiological parameter	4 yrs
Secondary	Clinical outcomes during pregnancy and postnatal/neonatal period: mode of birth	Mode of Delivery	4 yrs
Secondary	Clinical outcomes during pregnancy and postnatal/neonatal period: preterm birth	Number of preterm births by gestation per 1000 pregnancies	4 yrs
Secondary	Clinical outcomes during pregnancy and postnatal/neonatal period: stillbirth	Antenatal fetal loss rate per 1000 pregnancies	4 yrs
Secondary	Clinical outcomes during pregnancy and postnatal/neonatal period: intrapartum stillbirth	Intrapartum fetal loss rate per 1000 pregnancies	4 yrs
Secondary	Clinical outcomes during pregnancy and postnatal/neonatal period: neonatal death	Neonatal death <30 days of age: rate per 1000 livebirths	4 yrs
Secondary	Clinical outcomes during pregnancy and postnatal/neonatal period: infant	Neonatal/infant death >30 days of age <1year of age: per 1000 live births	4 yrs
Secondary	Clinical outcomes during pregnancy and postnatal/neonatal period: neonatal admission	Adverse neonatal outcome - planned/unplanned admission to NICU: rate per 1000 pregnancies	4 yrs
Secondary	Clinical outcomes during pregnancy and postnatal/neonatal period: HIE	Adverse neonatal outcome - diagnosis of HIE rate per 1000 pregnancies	4 yrs
Secondary	Clinical outcomes during pregnancy and postnatal/neonatal period: cord gas	Cord Blood Gases outside normal range (umbilical cord arterial pH at birth <7.00 and <7.05)	4 yrs
Secondary	Clinical outcomes during pregnancy and postnatal/neonatal period: Apgar	Apgar score at birth (continuous variable and rate of <7 at 5 mins)	4 yrs
Secondary	Clinical outcomes during pregnancy and postnatal/neonatal period: size	Small for Gestational Age birthweight - by Hadlock and Intergrowth centiles. Physiological parameter	4 yrs
Secondary	Normal ranges of antenatal ultrasound markers.	Development of normal range of routinely collected ultrasound measurements. Physiological parameter	4 yrs
Secondary	Normal ranges of intrapartum markers.	Cardiotocograph results ( Dawes Redman Criteria). Physiological parameter	4 yrs